Avalon Fetal Monitor FM20 Avalon FM20 Fetal MonitorRecalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00884838000407), received between Mar 26, 2021 and Jul 21, 2026 — classified as 1 injury, 125 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (53 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 26, 2026Class IIOpen, Classified

   Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

   Z-2522-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2026No Audible Prompt/Feedback

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25893449 ↗
• MalfunctionJul 16, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25842806 ↗
• MalfunctionJul 10, 2026No Audible Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25788886 ↗
• MalfunctionApr 28, 2026No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON AN AVALON FM20 FETAL MONITOR INDICATING THERE WAS AN ALARM AND NO AUDIBLE SOUND COMING FROM THE SPEAKER. THE DEVICE WAS NOT IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25014469 ↗
• MalfunctionApr 13, 2026No Audible Alarm

  CUSTOMER REPORTED THAT THE DEVICE IS SHOWING AN INOP SPEAKER MALFUNCTION. IT WAS CONFIRMED THE DEVICE DID NOT PRODUCE SOUND AT THE TIME OF THE REPORT. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24854190 ↗
• MalfunctionFeb 6, 2026No Device Output

  IT WAS REPORTED THE FETAL MONITOR COULD NOT DETECT UTERINE CONTRACTIONS DUE TO AN INSENSITIVE TRANSDUCER PROBE, SO THE MONITOR WAS EXCHANGED IMMEDIATELY TO CONTINUE MONITORING. THE PATIENT WAS ADMITTED FOR TERMINATION OF THE PREGNANCY AT 38 WEEKS TWO DAYS AND UTERINE CONTRACTIONS COULD NOT BE MEASURED ADEQUATELY. THE CUSTOMER INDICATED THIS ISSUE COULD HAVE LED TO INADEQUATE OBSERVATION DURING LABOR AND RAPID DELIVERY. IN ADDITION, THE FEEDBACK FORM INDICATED THIS WAS A SERIOUS INJURY WITH THE INJURY BEING AN INCREASE IN CESAREAN SECTION RATE; HOWEVER, THIS PATIENT DID NOT HAVE A CESAREAN FOR THIS EVENT. IT WAS CLARIFIED THERE WAS NO ACTUAL HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278504 ↗
• MalfunctionJan 20, 2026No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM20 FETAL MONITOR INDICATING THAT THERE WAS NO SOUND AND NO IMAGE. THE DEVICE WAS IN CLINICAL USE ON A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121846 ↗
• MalfunctionJan 7, 2026No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON AN AVALON FM20 FETAL MONITOR INDICATING THAT A 715 PREGNANT WOMAN NEEDED TO UNDERGO FETAL HEART MONITORING. THE NURSE TURNED ON THE MACHINE AND PLACED THE FETAL HEART PROBE ON THE BACK OF THE PREGNANT WOMAN'S FETUS. THE DISPLAY SHOWED ABNORMAL FETAL HEART SOUNDS, AND THE NORMAL FETAL HEART SOUNDS WERE NOT AUDIBLE. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990641 ↗
• MalfunctionJan 5, 2026Signal Artifact/Noise

  PHILIPS RECEIVED A COMPLAINT ON AN AVALON FM20 FETAL MONITOR INDICATING THAT THE CARDIOTOCOGRAPH SHOWS NOISE AT THE FOCUS INPUT. IT IS UNKNOW IF THE DEVICE WAS IN USE AT TIME OF EVENT, NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955596 ↗
• MalfunctionDec 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE FETAL HEART MONITORING WAS INACCURATE. THE ACTUAL VALUE WAS 130, BUT THE DISPLAY SCREEN SHOWED 220. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786720 ↗
• MalfunctionDec 5, 2025High Readings; High Readings

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM20 FETAL MONITOR INDICATING THAT THERE WAS A LARGE FHR (FETAL HEART RATE) ERROR WHERE THE VALUE EXCEEDED 200. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728925 ↗
• MalfunctionDec 3, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM20 FETAL MONITOR INDICATING THAT THE PARAMETERS OF THE MONITOR WERE FLUCTUATING ABNORMALLY AND WERE INACCURATE. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT; THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707893 ↗
• MalfunctionNov 25, 2025No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM20 FETAL MONITOR INDICATING THE ALARM TONES CANNOT BE HEARD. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649650 ↗
• MalfunctionNov 17, 2025No Audible Alarm; No Audible Prompt/Feedback; No Audible Alarm; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THERE WAS ERROR MESSAGE "SPEAKER MALFUNCTION" OCCURS. THE DEVICE IS IN CLINICAL USE AT TIME OF EVENT, NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575985 ↗
• MalfunctionOct 28, 2025No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THE SPEAKER WAS FAULTY. IT WAS CONFIRMED THE DEVICE NEITHER PRODUCED SOUND NOR DID IT SHOW AN INOPERATIVE SPEAKER MESSAGE AT THE TIME OF THE REPORT. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408513 ↗
• MalfunctionOct 20, 2025No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM20 FETAL MONITOR INDICATING THERE WAS A SPEAKER MALFUNCTION AND THERE WAS CONFIRMED NO AUDIO. THE DEVICE WAS NOT IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336145 ↗
• MalfunctionOct 16, 2025Signal Artifact/Noise; Signal Artifact/Noise

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM20 FETAL MONITOR INDICATING THE CARDIOTOCOGRAPH SHOWS NOISE AT THE FOCUS INPUT. IT IS KNOWN THAT THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23314716 ↗
• MalfunctionOct 15, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  PHILIPS RECEIVED A COMPLAINT ON AN AVALON FM20 FETAL MONITOR INDICATING THAT DURING A FETAL HEART MONITORING PROCEDURE, THE NURSE NOTED THERE WAS SIGNIFICANT NOISE AND THE FETAL HEART RATE APPEARED TO BE AS HIGH AS 200 BEATS PER MINUTE. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279762 ↗
• MalfunctionSep 15, 2025No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM20 FETAL MONITOR INDICATING THAT DURING ROUTINELY PERFORMING FETAL HEART RATE MONITORING FOR A PATIENT IN THE OBSTETRICS DEPARTMENT, THE EQUIPMENT SUDDENLY LOST AUDIO OUTPUT. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23049244 ↗
• MalfunctionAug 14, 2025Incorrect Measurement; Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM20 FETAL MONITOR INDICATING THAT, WHEN IN USE WITH THE TOCO SENSOR, THE DEVICE DOES NOT PROVIDE ACCURATE MEASUREMENT. THE VALUES ARE NOT RELIABLE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804768 ↗
• MalfunctionAug 13, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE FETAL MONITOR WAS NOT PRODUCING ANY SOUND. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795978 ↗
• MalfunctionAug 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM20 FETAL MONITOR INDICATING THAT A PREGNANT WOMAN CAME TO THE HOSPITAL FOR TREATMENT ON (B)(6), 2025, AT 20:27. ACCORDING TO THE DOCTOR'S ADVICE, A FETAL HEART RATE MONITOR WAS PERFORMED. DURING THE MONITORING PROCESS, THE FETAL MONITORING MACHINE SHOWED THAT THE FETAL HEART RATE FLUCTUATED BETWEEN 90 AND 210 BEATS PER MINUTE, INDICATING POOR FETAL MONITORING SIGNALS. THE DOCTOR WAS IMMEDIATELY INFORMED. THE DOPPLER AUSCULTATION OF THE FETAL HEART RATE WAS BETWEEN 130 AND 150 BEATS PER MINUTE, WHICH WAS WITHIN THE NORMAL RANGE. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22788836 ↗
• MalfunctionJul 25, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT A SPEAKER MALFUNCTION OCCURRED AND THE SPEAKER EMITS NO SOUND. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607579 ↗
• MalfunctionJul 18, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT A SPEAKER MALFUNCTION OCCURRED AND THE SPEAKER EMITS NO SOUND. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541595 ↗
• MalfunctionJul 11, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE AVALON FM20 FETAL MONITOR WAS EXPERIENCING A LOSS OF SOUND. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479036 ↗